UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002490 |
|---|---|
| Receipt number | R000003053 |
| Scientific Title | Pharmacogenetic analysis to investigate the association between efficacy and neurotoxicity of oxaliplatin and single nucleotide polymorphisms |
| Date of disclosure of the study information | 2009/11/10 |
| Last modified on | 2011/09/14 09:20:54 |
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Basic information
Public title
Pharmacogenetic analysis to investigate the association between efficacy and neurotoxicity of oxaliplatin and single nucleotide polymorphisms
Acronym
Pharmacogenetic analysis of oxaliplatin
Scientific Title
Pharmacogenetic analysis to investigate the association between efficacy and neurotoxicity of oxaliplatin and single nucleotide polymorphisms
Scientific Title:Acronym
Pharmacogenetic analysis of oxaliplatin
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association between the efficacy of oxaliplatin for liver metastasis and SNP of ERCC1-118 in colorectal cancer patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between the oxaliplatin-induced neurotoxicity and SNP of GSTP1-105.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the association between the efficacy of oxaliplatin for liver metastasis and SNP of ERCC1-118 in colorectal cancer patients.
Key secondary outcomes
To investigate the association between the oxaliplatin-induced neurotoxicity and SNP of GSTP1-105.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed colorectal cancer patients with measurable liver metastasis who received oxaliplatin-based chemotherapy as first line treatment
2. Written informed consent is provided
Key exclusion criteria
The patients with a history of adjuvant chemotherapy using oxaliplatin
Target sample size
133
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kanai |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
TEL
075-751-4770
Homepage URL
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pharmacogenetic analysis of oxaliplatin
Management information
Registered date
| 2009 | Year | 09 | Month | 14 | Day |
Last modified on
| 2011 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003053
